Field Service Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Engineering Supervisor

Director, Engineering Services

Manager, Operations

Wire/Cable Senior R&D/Product Development Engineer

Test engineer

Senior Quality Specialist, LIMS Administration

Responsibilities: <ul><li>Work independently on our client vacuum valves installation, troubleshooting, problem solving, maintenance and repairing on site/internal workshop.</li><li>Responds to customer calls; analyzes, and troubleshoots problems via phone, remote session or at customer site.&nbsp;&nbsp;</li><li>On time and correctly report working activities and time duration with customer signature.</li><li>Keep good communication with customers at various levels (tool engineers, section managers etc.)</li><li>Liaise with customers and internal stakeholders relating to technical and service issues.</li><li>Conducting customer support meetings and ensuring regular communication with customers.</li><li>Follow up and feedback customer complaints.</li><li>Follow up customer open issues until it closed.</li><li>Response for our client quality information collection and quality problem report.</li><li>Provide technical problem solving and roots cause analysis report.</li><li>Ability to support customer for urgent request in weekend and holiday.&nbsp;&nbsp;&nbsp;</li><li>Assessing customers’ needs and advice the customers with regards to spare parts, preventive maintenance and retrofit possibilities.</li><li>Special projects and other duties as assigned.&nbsp;&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Mechanical or electronic background with college degree or above.</li><li>Minimum 3 years of service experience in Cleanroom environment (Semiconductor or vacuum industry is preferred).</li><li>Strong skill of diagnosing, repairing and troubleshooting.</li><li>Strong business acumen and ability to identify opportunities within problems.</li><li>Be able to work independently under pressure and irregular hours.</li><li>Personal accountability, team player.</li><li>Good communication and interpersonal skill.</li><li>Goal achievement.</li><li>Willing and able to travel frequently within short notice. Be adapted to irregular over time work together with customer urgent need.</li><li>Able and comfortable to communicate in English, Chinese. And 1 other additional language is a plus. (Japanese or Korean).</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.</li><li>Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.</li><li>Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.</li><li>Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li></ul> Requirements: <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.</li><li>Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.</li><li>Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a cleanroom-based pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

Role Description: <ul><li>The Engineering Supervisor leads a team of skilled mechanics and technicians responsible for the maintenance, troubleshooting, and reliability of facility infrastructure, clean utilities, laboratory systems, and pharmaceutical production equipment at our new sterile injectable manufacturing site.</li><li>This individual will play a key leadership role in coaching, mentoring, and developing technical staff, while ensuring all maintenance activities are performed safely, efficiently, and in compliance with cGMP and regulatory requirements.</li><li>This is a pivotal role in a startup manufacturing environment, requiring strong leadership, technical depth, and a commitment to operational excellence and safety.</li></ul> Responsibilities: <ul><li>Supervise and develop a team of mechanics and technicians supporting facilities, utilities, lab and production equipment. Additional oversight of contractors will be expected.</li><li>Coach, train, and mentor team to build technical depth and promote a culture of ownership and continuous improvement.</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.</li><li>Conduct performance reviews, skill assessments, and development planning for direct reports.</li><li>Lead the maintenance, calibration, and repair of critical systems including HVAC, compressed air, WFI, clean steam, Nitrogen generation, isolators, fillers, automated inspection and leak detection equipment, automated secondary packaging equipment, lab systems, stability chambers, site infrastructure, and the Building Management System (BMS).</li><li>Ensure all activities are conducted in compliance with cGMP, safety regulations, maintenance plans and SOPs.</li><li>Support commissioning, qualification (IQ/OQ/PQ), and startup activities for new systems and equipment.</li><li>Drive proactive and preventive maintenance through CMMS system utilization and performance tracking.</li><li>Ensure good documentation practices and data integrity so all maintenance records are accurate, complete, and auditable.</li><li>Enforce a culture of safety focusing on EHS compliance, including Lockout/Tagout, confined space entry, Arc flash protection, and chemical safety protocols.</li><li>Support audits and inspections by regulatory agencies and internal quality teams.</li><li>Analyze equipment performance and maintenance data to identify trends, root causes, and opportunities to reduce downtime and increase reliability.</li><li>Collaborate with engineers, production, and quality teams to improve reliability and maintainability of equipment.</li><li>Manage spare parts strategy and implement inventory management process.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate or bachelor’s degree in engineering, Facilities Management, Industrial Technology, or related field (or equivalent experience).</li><li>Minimum 5+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment, with 2+ years in a supervisory or team lead role.</li><li>Strong technical knowledge of clean utilities, facility systems, secondary packaging and aseptic manufacturing equipment.</li><li>Experience supervising or mentoring maintenance personnel.</li><li>Experience in controlled substance and high potent product environment desired.</li></ul> Skills/Competencies: <ul><li>Working knowledge of cGMPs, regulatory expectations, and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo, etc.)</li><li>Strong organizational, communication, and leadership skills.</li><li>Demonstrated commitment to safety, compliance, and team development.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.</li><li>Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.</li><li>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Role Description:&nbsp; <ul><li>As a Wire/Cable Senior R&amp;D/Product Development Engineer at our clienty, you will work in a dynamic, diverse environment focusing on the development and qualification of high-speed bulk cable products.</li><li>This role supports the full product lifecycle—from concept and design through testing, production, and release—while collaborating across engineering, manufacturing, and customer teams.</li></ul> Responsibilities:&nbsp; <ul><li>Lead the design, specification, and documentation of bulk cable Signal Integrity (SI) and physical testing interfaces for high-speed bulk cable applications.</li><li>Interact with Cable Assembly SI teams to correlate bulk cable data with cable assembly SI/physical test results.</li><li>Collaborate with customers and end-users to understand use case requirements and establish test specifications aligned with industry standards.</li><li>Work with internal and external vendors to design and implement test equipment and fixtures.</li><li>Develop, document, and maintain bulk cable SI/physical test protocols.</li><li>Train bulk cable test personnel across all our client DDN bulk cable locations on the use of testing fixtures and procedures.</li><li>Deliver technical presentations to both internal teams and external customers as needed.</li><li>Support and participate in company safety (SAFE) and ISO compliance activities.</li><li>Provide technical support for maintenance and calibration of bulk cable test equipment.</li><li>Contribute to cross-functional projects and initiatives supporting business objectives.</li></ul> Requirements:&nbsp; <ul><li>Strong knowledge of circuit analysis&nbsp;</li><li>Experience with reliability testing and engineering.</li><li>Proficient in using Network Analyzers and working with S-Parameters.</li></ul>

Responsibilities: <ul><li>Be familiar with ASTM/ISO test standards and internal specifications, develop corresponding operation procedures.</li><li>Carry out qualification tests according to specification/SOP, ensure test tasks can be finished within schedule.</li><li>Support PM to test competitor products and customer’s application test.</li><li>Learn to operate flame test chamber and master flammability test method per UL224 all tubing and VW-1.</li><li>Support to do verification test for NPD projects</li><li>Develop new and improve existing test capability based on product test requirement.</li><li>Carefully record test data and results, check and review test data to meet specification requirements.</li><li>Analyze root cause of test failure and propose corrective action.</li><li>Prepare relevant test reports.</li><li>Take part in document management training, then upload test reports into PDMlink for approval.</li><li>Be responsible for maintenance of test equipment and instruments, spot check equipment carefully.</li><li>Maintain equipment calibration list and perform regular outsourcing calibration before expiration.</li><li>Purchase expendable chemicals, spare parts and tools in time, ensure they are available in any time.</li><li>Implement 5S and personal protection per company’s policy, ensure tidy environment and safety in lab.</li><li>Train and qualify new technicians.</li><li>Other job assigned by lab supervisor.</li><li>Continuous improvement. Look for and suggest efficiency improvements within qualification laboratory.</li></ul> Requirements: <ul><li>College or bachelor degree with more than 2 years working experience, major in material science is preferred.</li><li>Proficient in listening, speaking, reading and writing with Mandarin and English.</li><li>Be good at thinking and strong practical ability.</li><li>Good communication and interpersonal skills.</li><li>Familiar with PC and office software.</li><li>Hard-working and studious.</li><li>Be careful and responsible.</li><li>Team-work spirit.</li><li>Able to manage multiple priorities.</li><li>Stress resistant.</li><li>Flexibility to travel to suppliers, customers, company location. In-line with local travel protocols.</li><li>Have knowledge of VW/BMW/Daimler OEM specification advantage, but not essential;</li><li>Compounding or extrusion advantage, but not essential.</li></ul>

Responsibilities: Data Entry &amp; Maintenance <ul><li>Prepares crystal reports</li><li>Creates or approves static data entries</li><li>Adds/modifies calculations, workflows, and schemas as necessary</li></ul> Configuration/Customization <ul><li>Codes LIMS system to customize software platform</li><li>Integrates and customizes software with laboratory instrumentation</li><li>Responsible for instrument integration</li><li>Builds Crystal Reports</li><li>Assess change controls as they pertain to LIMS requirements.</li><li>Builds/Configure Electronic Laboratory Notebooks</li></ul> New Phases <ul><li>Participate in cross-site implementation of new LIMS features and enhancements</li><li>Coordinates roll-out of additional LIMS phases</li><li>Assists in Project Planning and Budget Spending</li></ul> Audit&nbsp; <ul><li>Performs periodic audits on the system, collates and presents the results of the audit to senior management, as required</li></ul> Training&nbsp; <ul><li>Develop training modules and provide user training as necessary</li></ul> End-User Satisfaction&nbsp; <ul><li>Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary</li></ul> Collaboration&nbsp; <ul><li>Interface with IT department on global LIMS issues</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment</li></ul> Other <ul><li>Performs other LIMS-related responsibilities as required by management</li></ul> Requirements: Qualifications&nbsp;Education &amp; Experience <ul><li>Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory</li><li>3+ years’ experience within software development</li><li>Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Knowledge of 21 CFR Part 11</li><li>Strong knowledge of Computer System Validation techniques and practices</li><li>Company SOPs applicable to job</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>Strong understanding of Company SOPs applicable to job</li><li>GMP Knowledge of FDA regulations, primarily GMP regulations</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java</li></ul> Skills &amp; Abilities <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Advanced computer skills <ul><li>Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines</li><li>Strong interpersonal and communication skills; confident presenter, clear, concise technical writer. Able to interact with various departments and levels</li><li>Customer focused</li><li>Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions</li></ul> Physical Requirements <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Ability to lift 15 lbs.</li><li>Ability to walk across plant/laboratory</li><li>Travel up to 20% of the time may be required</li></ul>

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15 calibration Jobs found

Field Service Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Engineering Supervisor

Director, Engineering Services

Manager, Operations

Wire/Cable Senior R&D/Product Development Engineer

Test engineer

Senior Quality Specialist, LIMS Administration

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Skills

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15 calibration Jobs found

Field Service Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Facility Engineer

Engineering Supervisor

Director, Engineering Services

Manager, Operations

Wire/Cable Senior R&D/Product Development Engineer

Test engineer

Senior Quality Specialist, LIMS Administration

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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TALENT

COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.